Biomarkers for Predicting Neoadjuvant Chemoradio-resistance for Middle-low Advanced Rectal Cancer

NCT03573791 | Recruiting

• 1 other identifier: WHUHGE-R01
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 2

Brief Summary

Neoadjuvant therapy has been widely applied to locally advanced rectal cancer. However, about 50% of patients receiving this therapy do not respond well as evidenced by the fact that their T or N stages are not effectively decreased judged by postoperative pathological examination. The purpose of this trail is to identify the biomarkers (from within patients' tumor mass before neoadjuvant therapy) to predict resistance to neoadjuvant therapy. These biomarkers can help stratify neoadjuvant-resistant patients towards surgery while avoiding unnecessary chemoradio-based neoadjuvant therapy.

Conditions

Rectal Cancer; Cancer of Rectum; Cancer of the Rectum; Neoplasms, Rectal; Rectal Tumors; Rectum Cancer; Rectum Neoplasms

Outcome Measures

Primary Outcomes (1)

• Comparing gene expression differences between poor response group and complete response group by using RNA sequencing.

  Using RNA-seq sequencing method to obtain the whole genome transcription profiles of the poor response group and complete response group, and compare the gene expression differences between these two groups.

  6 months

Secondary Outcomes (2)

• Overall survival(OS)

  3 years

• Progression Free Survival(PFS)

  3 years

Study Arms (2)

Complete response

After neoadjuvant therapy, postoperative pathological examination will be performed to evaluate the efficacy of the therapy. Define postoperative staging ypT0N0 as complete response.

Poor response

After neoadjuvant therapy, postoperative pathological examination will be performed to evaluate the efficacy of the therapy. Define postoperative staging \>ypT1-2N0 as poor response.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All participants will be recruited from Wuhan Union Hospital or Hubei Cancer Hospital.

You may qualify if:

• Histopathology proved to be adenocarcinoma of the rectum.
• The edge of tumor is within 12cm of anus margin.
• According to the eighth edition of AJCC TNM staging standard ,that staging for Ⅱ-Ⅲ period, as T3-T4, N0 or any T, N1-2.
• There is no history of chemotherapy, radiotherapy or immunotherapy before neoadjuvant therapy.
• Understand and agree to sign the informed consent for the study.

You may not qualify if:

• With intestinal obstruction or impending obstruction, or perforation.
• With other malignancies occurred within 5 years.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (2)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

NOT YET RECRUITING

Related Publications (1)

• Chang GJ, Park IJ, You YN, et al. Neoadjuvant treatment response and outcomes in locally advanced rectal cancer: Establishing oncologic benchmarks. Journal of Clinical Oncology 29(15):3545-3545,2011.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor biopsy samples are collected before neoadjuvant therapy when participants undergo colonoscopy or endoscopic ultrasonography. Two pieces of tumor tissue specimens will be extracted. These tissues will be stored at the tumor specimen bank and gene expression profile of these tumor samples will be analyzed using RNA sequencing.

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zheng Wang, MD/PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Zheng Wang, MD/PhD

CONTACT

+86 27 85726612; zhengwang@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study chair, Clinical Professor

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: June 29, 2018
• Study Start: May 21, 2018
• Primary Completion (Estimated): May 21, 2026
• Study Completion (Estimated): May 21, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)